Guidance document : post-notice of compliance (NOC) changes : framework document (pharmaceutical, biologic and radiopharmaceutical drugs for human use only).: H13-9/31-2019E-PDF
"After a new drug as defined in section C.08.001 of the Food and Drug Regulations has been granted a Notice of Compliance (NOC), it is not uncommon for sponsors to make changes to the drug. A post-NOC change is any change that is made to a new drug that has received a NOC pursuant to section C.08.004 of the Food and Drug Regulations. Many of these changes may be made to improve the quality of the drug product or the efficiency of the manufacturing process, or they could be made for marketing considerations. Changes to the labelling of a drug product could include adding new indications, improving the management of risk for a product by adding warnings, limiting the target population or changing the dosage regime etc."--Introduction, page 6.
Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.866456&sl=0
| Department/Agency | Canada. Health Canada, issuing body. |
|---|---|
| Title | Guidance document : post-notice of compliance (NOC) changes : framework document (pharmaceutical, biologic and radiopharmaceutical drugs for human use only). |
| Variant title | Post-notice of compliance (NOC) changes : framework document (pharmaceutical, biologic and radiopharmaceutical drugs for human use only) |
| Publication type | Monograph |
| Language | [English] |
| Other language editions | [French] |
| Format | Electronic |
| Electronic document | |
| Note(s) | Cover title. Issued also in HTML format. "Effective date: 2020/04/01." Issued also in French under title: Ligne directrice : changements survenus après l’avis de conformité (AC) : document cadre (médicaments pharmaceutiques, biologiques et radiopharmaceutiques à usage humain seulement). |
| Publishing information | Ottawa, ON : Health Canada = Santé Canada, 2019. ©2020 |
| Description | 1 online resource (16 pages) |
| ISBN | 9780660291475 |
| Catalogue number |
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| Departmental catalogue number | 180707 |
| Subject terms | Drugs -- Labeling -- Canada. Drug approval -- Canada. |